The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence

The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence: Sequential, Multiple Assignment, Randomized Controlled Trial (SMARTs)

A sequential multiple-assignment randomized controlled trial (SMART) will be used to assess the effect of an adaptive stepped-care intervention on FCR in cancer survivors with subclinical levels of fear of cancer recurrence.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Fear of Cancer Recurrence
• Intervention / Treatment: Behavioral: eConquerFear; Behavioral: eHealthMaintenance; Behavioral: ConquerFear; Behavioral: Group-delivered ConquerFear-HK

Detailed Description

The current SMART trial aims to address the following research questions and hypotheses:

1. What is the best initial low-intensity unsupervised self-guided e-intervention for managing subclinical FCR? Hypothesis 1: It is better to begin adaptive interventions with eConquerFear than with eHealthMaintenance. This hypothesis will address the main effect of the first-stage intervention.
2. What is the best treatment option for non-respondents to initial adaptive interventions? Hypothesis 2: Among initial non-respondents, it is better to switch to supervised, individual, face-to-face ConquerFear than to group-delivered ConquerFear. This hypothesis will address the main effect of the second-stage intervention.
3. Which of the four embedded adaptive interventions (1. eConquerFear + group-delivered ConquerFear; 2. eConquerFear + Individual ConquerFear; 3. eHealthMaintenance + group-delivered ConqerFear; 4. eHealthMaintenance + Individual ConquerFear) leads to the greatest reduction in FCR? Hypothesis 3: eConquerFear + Individual ConquerFear will lead to the greatest reduction in FCR. This hypothesis will identify the best adaptive intervention.
4. Given that the ConquerFear intervention aims to modify unhelpful metacognitive beliefs and cognitive-attentional syndrome (CAS), we will test if the effect of stepped-care ConquerFear intervention on FCR is mediated by its effect on maladaptive metacognition and CAS. We hypothesize that there would be an indirect effect of stepped-care ConquerFear intervention on FCR through its effect on maladaptive metacognition and CAS (Hypothesis 4).

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle Ng, PhD; Phone Number: +852 39179897; Email: dwlng@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • QMh department of surgery
    • Contact: CC Foo; Phone Number: 85222554389; Email: ccfoo@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Cantonese- or Mandarin-speaking Chinese patients diagnosed with curable breast, colorectal, or gynecological cancer, who had completed treatment (except endocrine therapy) within five years, and with a Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) score of 13 to 21 indicating subclinical FCR will be included.

Exclusion Criteria:

• Patients with metastatic cancer, with a current diagnosis of depression or psychosis, or who are already receiving psychological treatment will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: First stage intervention: eConquerFear; Participants in the eConquerFear intervention group will receive six online modules with each containing educational text, illustrative graphics, interactive exercises, and brief videos. Every module will teach a specific topic, such as self-examination and medical surveillance, values-based goal setting, attention training, detached mindfulness, worry management and treatment summary and relapse prevention.	Behavioral: eConquerFear; The key goals of this e-intervention are to: (i) teach strategies for controlling worry and excessive threat monitoring; (ii) modify underlying unhelpful MCQ beliefs about worry; (iii) develop appropriate monitoring and screening behaviours, (iv) encourage acceptance of the uncertainty brought about by a cancer diagnosis, and (v) clarify values and encourage engagement in values-based goal setting.
Active Comparator: First stage intervention: eHealthMaintenance; Participants in the eHealthMaintenance group will receive six videos, which were designed to provide comprehensive lifestyle guidance (e.g., relaxation techniques, diet and physical activity advices) to help with survivors' maintenance of health in long-term.	Behavioral: eHealthMaintenance; eHealthMaintenance is not developed specifically to target fear of cancer recurrence through modifying participants' cognitive beliefs. Participants in this arm will receive 6 videos about relaxation, generic dietary and exercise knowledge.
Experimental: Second stage intervention: ConquerFear-HK; ConquerFear-HK is a culturally adapted, manualized intervention consisting of 6 individual face-to-face sessions over 10 weeks.	Behavioral: ConquerFear; ConquerFear is an intensive version of eConquerFear, which consists of 6 face-to-face therapist-led sessions.
Active Comparator: Second stage intervention: Group-delivered ConquerFear-HK; Group-delivered ConquerFear-HK is a manualized six-session intervention over 10 weeks. The key goals of the intervention are identical to the individual-based ConquerFear manualized intervention.	Behavioral: Group-delivered ConquerFear-HK; Group-delivered ConquerFear-HK is a manualized six-session intervention over 10 weeks. The key goals of the intervention are identical to the individual-based ConquerFear manualized intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of fear of cancer recurrence (FCR)	The primary outcome is the change in the total score of FCR assessed using the 42-item Fear of Cancer Recurrence Inventory (FCRI). The FCRI measures seven dimensions of FCR: (1) triggers, (2) severity, (3) psychological distress, (4) functional impairment, (5) reassurance, (6) insights, and (7) coping strategies. All items are rated on 5-point Likert scales ranging from 0 (not at all or never) to 4 (a great deal or all the time). Higher scores indicate higher levels of FCR.	baseline, 1-week post e-intervention (T1), immediately post stepped care intervention (T2), and six months post stepped care intervention (T3).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of metacognitions	Metacognition assessed by the 30-item Metacognitions Questionnaire (MCQ). The MCQ assesses individual differences in metacognitive beliefs, judgements, and monitoring tendencies across five domains: (1) positive beliefs about worry, (2) negative beliefs about thoughts concerning uncontrollability and danger, (3) cognitive confidence, (4) cognitive self-consciousness, and (5) the need to control thoughts. All items are rated on a 4-point Likert scale ranging from 1 (do not agree) to 4 (agree very much). Higher scores indicate higher levels of maladaptive metacognition.	baseline, 1-week post e-intervention (T1), immediately post stepped care intervention (T2), and six months post stepped care intervention (T3).
Change of cognitive attentional syndrome	CAS measured by the 16-item Cognitive Attentional Syndrome-1 (CAS-1) questionnaire.The CAS-1 assesses the frequency of engaging in rumination, threat monitoring, and coping behaviors, as well as the level of metacognitive beliefs. Each item is rated on a 9-point Likert scale ranging from 0 to 8, except for items measuring metacognitive beliefs, which are rated on a scale from 0 to 100. Higher scores indicate higher levels of CAS activation.	baseline, 1-week post e-intervention (T1), immediately post stepped care intervention (T2), and six months post stepped care intervention (T3).

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Wendy Lam, PhD, School of Public Health, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): August 31, 2026
• Last Update Submitted That Met QC Criteria: August 26, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Sequential multiple assessment randomized controlled trial; psychooncology; stepped-up care
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Neoplasms
• Other Study ID Numbers: FCR-SMART

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication will be available from the PI upon reasonable request.
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Access Criteria: Information will be available from the PI upon reasonable request. The author to review requests is the PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No